Symptomatic Irreversible Pulpitis and Post Operative PainNCT07663227
Ultrasonic Activated Irrigation and Intracanal Cryotherapy for Reducing Pain After Root Canal Treatment
A study testing Ultrasonic Activated Irrigation and Intracanal cryotherapy in people with Symptomatic Irreversible Pulpitis and Post Operative Pain, run by Dr Arsalan Ali Khan.
Trial summary
This randomized controlled trial aims to evaluate the effect of ultrasonic activated irrigation with and without intracanal cryotherapy on postoperative pain following single-visit root canal treatment in teeth with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis and Post Operative Pain
- What is being tested?
- Ultrasonic Activated Irrigation and Intracanal cryotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Patients who are medically fit (ASA Physical Status I) and aged between 20 and 50 years will be recruited for the study.
- 2. Mandibular first or second molars exhibiting signs of symptomatic irreversible pulpitis, identified through an extended sensitivity to cold testing and/or a positive electric pulp test.
- 3.Vital pulp with no signs of apical pathology (normal periapical radiograph, no swelling, sinus tract, or mobility).
- 4. Mature roots with closed apices and no prior root canal treatment. 5. Willing to undergo single-visit treatment and comply with follow-up.
Who cannot join
- 1.Use of analgesics or NSAIDs within 12 hours prior to treatment. 2.Pregnant or lactating women. 3.Presence of systemic illness or allergy to any materials used in the study. 4.Teeth with:
- Non-vital pulp, periapical radiolucency, or sinus tract.
- Mobility > Grade I or periodontal pockets > 5 mm.
- Resorption, calcification, or non-restorable crown structure. 5.Third molars (wisdom teeth). 6.Endodontically treated tooth. 7.Inability or unwillingness to follow study instructions or complete follow-up.
About this study
Official title: Effect of Using Ultrasonic Activated Irrigation, With and Without Intracanal Cryotherapy, on Post-Operative Pain After Single Visit Root Canal Treatment of Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effect of ultrasonic activated irrigation with and without intracanal cryotherapy on postoperative pain following single-visit root canal treatment in teeth with symptomatic irreversible pulpitis.
Participants requiring root canal treatment will be randomly allocated into two groups. One group will receive ultrasonic activated irrigation alone, while the other group will receive ultrasonic activated irrigation followed by intracanal cryotherapy. Postoperative pain will be assessed at predetermined time intervals using a standardized pain assessment scale.
The findings of this study may help identify effective strategies for reducing postoperative pain after root canal treatment and improving patient comfort and treatment outcomes.
Read the detailed description
Postoperative pain remains one of the most common complications following root canal treatment and may negatively affect patient comfort and treatment acceptance. Various factors, including preoperative status, instrumentation techniques, and irrigation protocols, influence the incidence and severity of post-endodontic pain.
Ultrasonic activated irrigation (UAI) enhances the effectiveness of irrigants by generating acoustic streaming and cavitation, thereby improving debris removal, smear layer elimination, and disinfectant penetration into the root canal system. Intracanal cryotherapy, which involves the application of cold saline as a final irrigant, has been proposed as a non-pharmacological method to reduce postoperative pain by decreasing tissue temperature and exerting anti-inflammatory effects.
This study is a single-center, parallel two-arm, single-blinded randomized controlled trial conducted at the Department of Operative Dentistry and Endodontics, Sardar Begum Dental College, Peshawar, Pakistan. A total of 60 patients aged 20 to 50 years diagnosed with symptomatic irreversible pulpitis in mandibular first or second molars will be enrolled.
Eligible participants will be randomly allocated into two groups using a computer-generated randomization sequence with allocation concealment through sealed opaque envelopes. Group A (control group) will receive ultrasonic activated irrigation without intracanal cryotherapy, whereas Group B (intervention group) will receive ultrasonic activated irrigation followed by intracanal cryotherapy using 0.9% saline at 1.5-2.5°C for 5 minutes.
All treatments will be performed in a single visit under local anesthesia and rubber dam isolation using standardized clinical protocols. Root canal preparation will be carried out using the ProTaper Universal rotary system. Ultrasonic activation will be performed for one minute per canal. Following obturation and permanent restoration, postoperative pain will be assessed using a 10-point Visual Analogue Scale (VAS).
Pain scores will be recorded at 12, 24, 48, and 72 hours postoperatively through telephone follow-up by a blinded assessor. The primary outcome measure is postoperative pain intensity. Analgesic consumption and adverse events will also be documented.
The findings of this study may provide evidence regarding the effectiveness of intracanal cryotherapy as an adjunct to ultrasonic activated irrigation for reducing postoperative pain following single-visit root canal treatment in teeth with symptomatic irreversible pulpitis.
- Being tested
- Ultrasonic Activated Irrigation, Intracanal cryotherapy
- Keywords
- Symptomatic irreversible pulpitis, Intracanal Cryotherapy, Ultrasonic Activated Irrigation, Postoperative Pain, Single-visit Root Canal Treatment
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic Activated IrrigationProcedure or surgery
Ultrasonic activation of 5.25% sodium hypochlorite was performed for one minute per canal, 1 mm short of the working length, during single-visit root canal treatment to enhance irrigant penetration and canal debridement.
Intracanal cryotherapyProcedure or surgery
Intracanal cryotherapy was performed by delivering 10 mL of cold 0.9% saline (1.5-2.5°C) passively 1 mm short of the working length over 5 minutes as the final irrigation step during single-visit root canal treatment.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonic Activated Irrigation Without Intracanal Cryorherapy | Active comparator | Participants assigned to this arm will undergo single-visit root canal treatment under local anesthesia and rubber dam isolation. Root canal preparation will be performed using the ProTaper Universal rotary system. Irrigation during instrumentation will be carried out using 5.25% sodium hypochlorite with ultrasonic activation for one minute per canal. At the final irrigation stage, 10 mL of room-temperature 0.9% saline will be delivered over 5 minutes. The canals will then be obturated and permanently restored in the same visit. Receives: Procedure: Ultrasonic Activated Irrigation |
| Ultrasonic Activated Irrigation With Intracanal Cryotherapy | Experimental | Participants assigned to this arm will undergo single-visit root canal treatment under local anesthesia and rubber dam isolation. Root canal preparation will be performed using the ProTaper Universal rotary system. Irrigation during instrumentation will be carried out using 5.25% sodium hypochlorite with ultrasonic activation for one minute per canal. At the final irrigation stage, 10 mL of cold (1.5-2.5°C) 0.9% saline will be delivered 1 mm short of the working length over 5 minutes as intracanal cryotherapy. The canals will then be obturated and permanently restored in the same visit. Receives: Procedure: Ultrasonic Activated Irrigation; Procedure: Intracanal cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using a 10-point Visual Analogue Scale (VAS). Pain scores will be recorded through telephone follow-up at 12, 24, 48, and 72 hours after completion of single-visit root canal treatment.
Measured: 12,24,48 and 72 hours after the completion of single-visit root canal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible Pulpitis and Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with symptomatic irreversible pulpitis in mandibular first or second molars will be randomly allocated into two parallel groups. Group A will receive ultrasonic activated irrigation without intracanal cryotherapy, while Group B will receive ultrasonic activated irrigation followed by intracanal cryotherapy using 0.9% saline at 1.5-2.5°C for 5 minutes. All root canal treatments will be completed in a single visit, and postoperative pain will be assessed at 12, 24, 48, and 72 hours using a Visual Analogue Scale (VAS).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Arsalan Ali Khan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Arsalan Ali Khan, College of Physicians and Surgeons Pakistan
- Investigators
- Shakeel Ur Rehman Khattak, BDS,BSc,MHR,FCPS, Study chair, Sardar Begum Dental College,Gandhara University,Peshawar,Pakitstan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663227
- Sponsor's protocol ID
- GU/Ethical Committee/2025/248
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because this is an investigator-initiated academic study, and no formal data-sharing plan has been established. Participant confidentiality and privacy will be maintained in accordance with institutional ethical guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Ultrasonic Activated Irrigation, With and Without Intracanal Cryotherapy, on Post-Operative Pain After Single Visit Root Canal Treatment of Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07663227
- Acronym / sponsor ID
- GU/Ethical Committee/2025/248
- Keywords
- Symptomatic irreversible pulpitis, Intracanal Cryotherapy, Ultrasonic Activated Irrigation, Postoperative Pain, Single-visit Root Canal Treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr Arsalan Ali KhanUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aims to evaluate the effect of ultrasonic activated irrigation with and without intracanal cryotherapy on postoperative pain following single-visit root canal treatment in teeth with symptomatic irreversible pulpitis.
Participants requiring root canal treatment will be randomly allocated into two groups. One group will receive ultrasonic activated irrigation alone, while the other group will receive ultrasonic activated irrigation followed by intracanal cryotherapy. Postoperative pain will be assessed at predetermined time intervals using a standardized pain assessment scale.
The findings of this study may help identify effective strategies for reducing postoperative pain after root canal treatment and improving patient comfort and treatment outcomes.
Detailed description
Postoperative pain remains one of the most common complications following root canal treatment and may negatively affect patient comfort and treatment acceptance. Various factors, including preoperative status, instrumentation techniques, and irrigation protocols, influence the incidence and severity of post-endodontic pain.
Ultrasonic activated irrigation (UAI) enhances the effectiveness of irrigants by generating acoustic streaming and cavitation, thereby improving debris removal, smear layer elimination, and disinfectant penetration into the root canal system. Intracanal cryotherapy, which involves the application of cold saline as a final irrigant, has been proposed as a non-pharmacological method to reduce postoperative pain by decreasing tissue temperature and exerting anti-inflammatory effects.
This study is a single-center, parallel two-arm, single-blinded randomized controlled trial conducted at the Department of Operative Dentistry and Endodontics, Sardar Begum Dental College, Peshawar, Pakistan. A total of 60 patients aged 20 to 50 years diagnosed with symptomatic irreversible pulpitis in mandibular first or second molars will be enrolled.
Eligible participants will be randomly allocated into two groups using a computer-generated randomization sequence with allocation concealment through sealed opaque envelopes. Group A (control group) will receive ultrasonic activated irrigation without intracanal cryotherapy, whereas Group B (intervention group) will receive ultrasonic activated irrigation followed by intracanal cryotherapy using 0.9% saline at 1.5-2.5°C for 5 minutes.
All treatments will be performed in a single visit under local anesthesia and rubber dam isolation using standardized clinical protocols. Root canal preparation will be carried out using the ProTaper Universal rotary system. Ultrasonic activation will be performed for one minute per canal. Following obturation and permanent restoration, postoperative pain will be assessed using a 10-point Visual Analogue Scale (VAS).
Pain scores will be recorded at 12, 24, 48, and 72 hours postoperatively through telephone follow-up by a blinded assessor. The primary outcome measure is postoperative pain intensity. Analgesic consumption and adverse events will also be documented.
The findings of this study may provide evidence regarding the effectiveness of intracanal cryotherapy as an adjunct to ultrasonic activated irrigation for reducing postoperative pain following single-visit root canal treatment in teeth with symptomatic irreversible pulpitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants with symptomatic irreversible pulpitis in mandibular first or second molars will be randomly allocated into two parallel groups. Group A will receive ultrasonic activated irrigation without intracanal cryotherapy, while Group B will receive ultrasonic activated irrigation followed by intracanal cryotherapy using 0.9% saline at 1.5-2.5°C for 5 minutes. All root canal treatments will be completed in a single visit, and postoperative pain will be assessed at 12, 24, 48, and 72 hours using a Visual Analogue Scale (VAS).
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic Activated Irrigation Without Intracanal Cryorherapy | Active comparator | Procedure: Ultrasonic Activated IrrigationParticipants assigned to this arm will undergo single-visit root canal treatment under local anesthesia and rubber dam isolation. Root canal preparation will be performed using the ProTaper Universal rotary system. Irrigation during instrumentation will be carried out using 5.25% sodium hypochlorite with ultrasonic activation for one minute per canal. At the final irrigation stage, 10 mL of room-temperature 0.9% saline will be delivered over 5 minutes. The canals will then be obturated and permanently restored in the same visit. |
| Ultrasonic Activated Irrigation With Intracanal Cryotherapy | Experimental | Procedure: Ultrasonic Activated Irrigation, Procedure: Intracanal cryotherapyParticipants assigned to this arm will undergo single-visit root canal treatment under local anesthesia and rubber dam isolation. Root canal preparation will be performed using the ProTaper Universal rotary system. Irrigation during instrumentation will be carried out using 5.25% sodium hypochlorite with ultrasonic activation for one minute per canal. At the final irrigation stage, 10 mL of cold (1.5-2.5°C) 0.9% saline will be delivered 1 mm short of the working length over 5 minutes as intracanal cryotherapy. The canals will then be obturated and permanently restored in the same visit. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1. Patients who are medically fit (ASA Physical Status I) and aged between 20 and 50 years will be recruited for the study.
- 2. Mandibular first or second molars exhibiting signs of symptomatic irreversible pulpitis, identified through an extended sensitivity to cold testing and/or a positive electric pulp test.
- 3.Vital pulp with no signs of apical pathology (normal periapical radiograph, no swelling, sinus tract, or mobility).
- 4. Mature roots with closed apices and no prior root canal treatment. 5. Willing to undergo single-visit treatment and comply with follow-up.
Key exclusion criteria (4 listed)
- 1.Use of analgesics or NSAIDs within 12 hours prior to treatment. 2.Pregnant or lactating women. 3.Presence of systemic illness or allergy to any materials used in the study. 4.Teeth with:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonic Activated IrrigationUltrasonic activation of 5.25% sodium hypochlorite was performed for one minute per canal, 1 mm short of the working length, during single-visit root canal treatment to enhance irrigant penetration and canal debridement. | Procedure or surgery | Ultrasonic Activated Irrigation With Intracanal Cryotherapy, Ultrasonic Activated Irrigation Without Intracanal Cryorherapy |
| Intracanal cryotherapyIntracanal cryotherapy was performed by delivering 10 mL of cold 0.9% saline (1.5-2.5°C) passively 1 mm short of the working length over 5 minutes as the final irrigation step during single-visit root canal treatment. | Procedure or surgery | Ultrasonic Activated Irrigation With Intracanal Cryotherapy |
Primary outcome
Postoperative Pain Intensity
Time frame: 12,24,48 and 72 hours after the completion of single-visit root canal treatment
Postoperative pain intensity will be assessed using a 10-point Visual Analogue Scale (VAS). Pain scores will be recorded through telephone follow-up at 12, 24, 48, and 72 hours after completion of single-visit root canal treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because this is an investigator-initiated academic study, and no formal data-sharing plan has been established. Participant confidentiality and privacy will be maintained in accordance with institutional ethical guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shakeel Ur Rehman Khattak, BDS,BSc,MHR,FCPS study chair
Sardar Begum Dental College,Gandhara University,Peshawar,Pakitstan
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic Activated Irrigation and Intracanal cryotherapy in people with Symptomatic Irreversible Pulpitis and Post Operative Pain, run by Dr Arsalan Ali Khan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: 12,24,48 and 72 hours after the completion of single-visit root canal treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.